|Publication number||US7001433 B2|
|Application number||US 10/282,620|
|Publication date||Feb 21, 2006|
|Filing date||Oct 29, 2002|
|Priority date||May 23, 2002|
|Also published as||CN1668259A, EP1513475A1, EP1513475A4, US8262731, US20030220691, US20050256581, WO2003099172A1|
|Publication number||10282620, 282620, US 7001433 B2, US 7001433B2, US-B2-7001433, US7001433 B2, US7001433B2|
|Inventors||Matthew N. Songer, Thomas S. Kilpela, Brian P. Janowski, Gregory A. Berrevoets, Matthew P. Gephart|
|Original Assignee||Pioneer Laboratories, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (102), Non-Patent Citations (1), Referenced by (95), Classifications (50), Legal Events (8)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of Provisional Application No. 60/382,758, filed May 23, 2002.
Artificial disc technology has been employed to correct damaged spinal discs for relieving back pain and restoring or maintaining intervertebral spacing while attempting to minimize their constraining effects on the normal biomechanical movement of the spine. Two types of artificial discs have generally been employed: the artificial total disc which is designed to substitute for the entire disc, i.e. the annulus, nucleus and possibly the end plates as well; and the artificial nucleus where only the nucleus is replaced with the annulus and end plates remaining intact. The disc of the present invention is not intended to be limited to one or the other of the above types.
A number of prior artificial disc devices include upper and lower members that are rigidly fixed to the adjacent upper and lower vertebrae. These fixed members sandwich a bearing therebetween along which they can slide to allow for relative movement between the adjacent vertebrae, see, e.g. U.S. Patent Application Publication 2002/0035400. However, devices such as these usually require special surface materials and/or surface treatments that allow for bone ingrowth for fixing the members to the vertebrae. Moreover, these devices have had problems with migration where the intermediate bearing body shifts out from between the vertebrae, and thus generally require more complex shapes to form stops for resisting such disc shifting.
In a relatively early approach, a stainless steel ball was employed in the damaged disc area. The ball approach, while effective to provide a good range of motion, tended to create subsidence problems. Over time, the ball would crush into the end plates as loading was fairly concentrated over a small surface on the ball in engagement with the plates. In other words, since these ball implants were not of a size that enabled the load of the spine to be distributed evenly thereacross, the end plates tended to subside or fall around the ball.
There also has been focus on simply replacing the nucleus with a gelled substance either injected directly in the disc or provided in pouches to attempt to reinflate the annulus and provide for load bearing. However, these approaches are limited in their use to patients who have a substantially undamaged disc annulus.
Accordingly, there is a need for an artificial disc that does not significantly inhibit spine movement while still providing the load bearing and spacer functions akin to that of a normal, healthy spinal disc.
In accordance with one form of the present invention, an artificial disc device is provided including a central, enlarged bearing portion and an outer, annular bearing portion generally extending about the central bearing portion and allowing for movement therebetween. The inner or central, enlarged bearing portion preferably has a body including upper and lower arcuate surfaces or surface portions that can shift relative to the outer bearing portion as well as with respect to the confronting surfaces of the spine, such as the end plates of the vertebrae. In this regard, the arcuate surfaces are not rigidly fixed to the vertebrae and are curved so as to allow the upper and lower vertebrae to shift with respect to each other such as when the spine is bent from side to side or front to back and twists or turns. At the same time, the enlarged central bearing portion can engage in small indentations in the respective vertebral surfaces that keeps the central bearing in a relative locked position thereby preventing lateral shifting with respect to the vertebrae so that the implant does not migrate despite the shifting vertebrae above and below these bearing surfaces. Thus, the enlarged central bearing portion locates the artificial disc device relative to the vertebrae.
The main body of the central bearing or bearing portion or bearing assembly including the arcuate bearing surfaces thereof can be a hard metallic material or alloy for load bearing purposes. Alternatively, a hard plastic could be employed to provide the central bearing portion with resiliency under compressive loading. For shock absorption, the bearing body may be provided with a hollow core or one that is liquid or gel filled or filled with other elastic material. To vary the give or compressibility of the central bearing body, the size of the core could be enlarged or decreased accordingly, or the modulus of elasticity of the body material can be varied.
In one preferred form, the outer bearing portion has a body that includes radially inner surfaces adjacent the arcuate surfaces adapted or configured for allowing relative movement therebetween. The outer bearing shares the compressive loading generated between the vertebrae via upper and lower bearing surfaces or surface portions thereof so that the load is better distributed across the present artificial disc device minimizing localized forces thereon. With the provision of the outer bearing, the present device is well suited to avoid subsidence problems as could occur in prior devices having highly localized loading thereon.
The outer bearing or bearing assembly also may be constructed to provide improved shock absorption capabilities such as with an inner portion of the body that is softer than the harder outer portion. For example, an elastomeric layer of material can be employed between attached upper and lower bearing plates of the outer bearing, or the core layer of an annular portion and/or an inner ball bearing portion of the outer bearing can be of elastomeric or liquid gelled material. Manifestly, material combinations can also be employed to achieve desired shock absorption proportions. The outer bearing can further include a compression limiter so as to maintain proper tolerances between the outer bearing inner surfaces and the inner bearing surfaces in confronting relation therewith as the outer bearing is loaded. In this manner, the inner bearing maintains its freedom of movement despite the compressive loading that is being borne by the outer bearing, as will be described more fully hereinafter.
In one form, the artificial disc includes a central ball as the enlarged, central bearing portion with an annular body of the outer bearing extending thereabout. The upper and lower load bearing surfaces or surface portions of the outer bearing body preferably do not project axially as far toward the upper and lower vertebrae as the ball surface portions such as by having a larger radius of curvature than the radius of the ball. In other words, the load bearing surface portions have a more gradual curvature than the center bearing surface portions or for that matter they can have a flat configuration. This allows the enlarged ball to seat in the indents in the end plates for positioning the artificial disc securely between the vertebrae while the annular body is also effective in taking up the compressive loading between the upper and lower vertebrae.
In another form, the central bearing portion includes a pair of generally dome-shaped shell members that ride on a generally spherical inner bearing portion integral with the outer bearing portion for sliding thereover. In this regard, the inner bearing portion is integrally connected to the outer bearing portion via a circumferential web wall. The domes or shells are sized relative to the inner spherical bearing portion so that there are gap spaces between the peripheral edges of the domes and the web wall. The web wall positions the outer, annular load bearing portion such that interference with shifting of the domes on the central spherical bearing portion is minimized. Alternatively, snap-fitting the domes in place over the inner ball bearing portion could be employed; however, the above described loose-fitting construction is preferred to minimize binding of the dome shells under compressive load forces. In this manner, the domes can readily slide on the inner ball portion and, at the same time, the vertebral end plates or other vertebral surfaces in engagement with the arcuate surfaces of the domes can also shift with respect thereto to provide a bi-polar device with two interfaces that shift with respect to each other.
By having this bi-polar artificial disc construction, the stress and wear that would otherwise occur in either of the interfaces is decreased as one bearing interface can be shifting when the load on the other becomes too great. Lubricant can be provided between the dome shells and the inner bearing portion to reduce friction and wear therebetween. A seal ring attached adjacent or at the end edge of the shells for being carried therewith minimizes lubrication leakage while allowing the shells to slide over the spherical surface of the inner bearing portion in a low friction manner.
In the form illustrated in
When the implanted disc 10 undergoes compressive loading, the outer bearing 14, and in particular the upper and lower surface portions 28 and 30 thereof will substantially maintain the effective spacing between the vertebrae 20 and 22. Thus, in the present artificial disc device 10, the outer ring bearing body 17 shares the loading with the ball bearing body 13 created between the dynamically moving vertebrae 20 and 22 so as to avoid subsidence problems as occurred with prior ball bearing-type devices. Accordingly, in the disc 10, the outer bearing 14 generally will not allow the end plates to subside around the ball bearing 12.
As shown, the curvature of the upper and lower surface portions 28 and 30 of the outer bearing body 17 is more gradual than that of the arc surface portions 16 and 18 of the central ball bearing body 13 to provide it with a doughnut-type configuration. Accordingly, in the device 10, the surface portions 28 and 30 are part of a substantially continuously curved outer ring bearing surface 32 such that they curve around the radially outermost point 29 of the outer bearing body 17 to form an outwardly projecting convex configuration 29 for the outer surface 32 of the annular bearing 14. As such, the surface portions 16 and 18 extend to their greatest spacing at the central section 17 a adjacent the central opening 15 of the bearing body 17. At the thickest section 17 a, the spacing of the surface portions 16 and 18 is less than the diameter of the ball bearing 12 so that the surface portions 16 and 18 protrude from the opening 15 to extend above and below the respective outer bearing surface portions 28 and 30 for engaging in the concave depressions 27 and 29. The gradual curvature of the surface portions 28 and 30 allows the ring bearing 14 to better conform to the general concavity of the vertebral surfaces 20 a and 22 a including any attached end plates over time. By way of example and not limitation, the ball bearing diameter can be approximately between 6-18 mm and the maximum thickness of the outer bearing section 17 a can be approximately 16 mm. Manifestly, these sizes are to be tailored according to the anatomy of the patient being treated.
With the vertebrae 20 and 22 exerting compressive loading on the artificial disc device 10, the projecting surface portions 16 and 18 of the center ball bearing 12 will securely engage in the indented recesses 27 and 29 in the confronting vertebral surfaces 20 a and 22 a for seating the ball bearing 12 therein. As the spine moves causing relative shifting of the vertebrae 20 and 22 about the ball bearing 12 with it freely rotating in the recesses 27 and 29 as necessary, further loading is exerted on the device 10, with the surface portions 28 and 30 of the outer annular bearing 14 being effective to share with the ball bearing 12 the compressive loading that is generated between the vertebrae 20 and 22, and which further can act as a shock absorber for the high impact load bearing that may be needed between the vertebrae 20 and 22, such as described hereinafter. In this manner, the present artificial disc device 10 resists both migration by the seating of the central ball bearing 12 as well as avoiding subsidence problems by providing load bearing which is well distributed across a large radially extending surface area of the device 10 as by the device upper surfaces 16 and 28 and lower surfaces 18 and 30. For example, the distance from the central axis 19 of the ring bearing 14 extending through the opening 15 to the outer end 29 can be approximately 12 mm.
While other material selections are possible, it is presently contemplated that the inner ball bearing 12 preferably will be of a harder material than the outer bearing 14 so that the harder ball 12 is more apt to maintain its conformity with and thus stay seated in the indents 27 and 29 in the surfaces 20 a and 22 a. In this regard, the ball 12 can be of a biocompatible material including titanium or metallic material such as stainless steel, while the ring bearing 14 can be of a material of a lower modulus of elasticity such as plastic material, e.g polyethylene, so as to have some resilience under compressive loading forces.
With a plastic outer bearing 14, a support hoop 34 of a harder material than that of the outer bearing 14 such as of metal material similar to that of the ball bearing 12 can be embedded therein. Generally, the hardness of the ball bearing 12 and the hoop 34 will both be greater than the outer bearing 14, although they may not be the same as each other. For example, the hoop 34 can be of a hard metal material whereas the center bearing 12 can have a hardness similar to the human bone. To this end, the plastic outer bearing 14 can be a molded component of the artificial disc device 10. As such, the metal support hoop 34 can be molded in situ in the outer ring bearing 14. The support hoop 34 serves as a compression limiter to resist deformation of the resilient plastic ring bearing 14 due to the compressive loading generated between the vertebrae 20 and 22 so that it is better able to maintain its configuration despite the stresses exerted thereon. In addition, the hoop 34 also resists shear forces generated by spinal movements for reducing such forces in the resilient material of the outer bearing 14.
Alternatively, outer bearing body 17 can have an inner core portion that is of different and softer material than that of the harder outer portion so that the annular bearing 14 has improved shock absorbing properties for high force impacts on the artificial disc 10 with the harder outer layer minimizing wear on the bearing 14. For example, the wear layer can be of hard polyethylene material with the inner cushion material of the bearing body 17 being of a softer polymeric or elastomeric material. In another alternative, the body 17 can include a hollowed inner portion that is filled with liquid or gel or other elastic material, e.g. Hydrogel and/or polyurethane, for shock absorption purposes.
Other differences in the construction of the bearing 46 of the devices 36 and 38 relates to the plan configuration of the outer bearing portion 45. The devices 36 and 38 have their bearing portion 45 provided with a pair of lobe sections 48 and 50 that extend in a continuously curved path about the majority of their peripheries until the lobe perimeters meet at their juncture formed at a recessed area 52 therebetween. In this manner, the plan shape of the lobed bearing 46 more closely approximates that of the vertebrae 20 and 22 between which the devices 36 and 38 are implanted. Ring bearing 14 could be provided with a similar lobed plan configuration. Manifestly, the outer bearings 14 and 46 can be formed with other configuration, e.g. oval in plan, so as to be more closely match that of the intervertebral space in which they are to be implanted.
Another difference resides in the configurations of load bearing surface portions 54 and 56 of the bearing 46 generally corresponding to the load bearing surface portions 28 and 30 of the bearing 14. In contrast to the curvature of the surfaces 28 and 30 of the ring bearing 14, the surfaces 54 and 56 are shown as having a generally flat, parallel configuration so that the bearing body 43 has more of a disc or plate-like configuration. Generally, however, some curvature on these bearings surfaces 54 and 56 will be desirable although perhaps modified from that shown for bearing surfaces 28 and 30 for the implant 10. The surfaces 54 and 56 are provided with a spacing smaller than that of the diameter of the central bearing portion 44 and thus of the central bearing assembly 39 with the dome shells 40 and 42 thereon so that they project above and below the respective surfaces 54 and 56. In this manner, the dome shells 40 and 42 are able to seat in indents 27 and 29 in the vertebral surfaces 20 a and 22 a like the bearing ball surface portion 16 and 18. To this end, the shells 40 and 42 can be of harder material than that of the bearing body 43, and particularly the ball bearing portion 44 thereof. Accordingly, similar to the ball bearing 12, the dome shells 40 and 42 can be of a ceramic material or a stainless-steel metal, titanium or alloys thereof, whereas the ring bearing 46 is preferably of a plastic or polymer material such as polyethylene to provide it with stiffness and resiliency under compressive loading. The bearing 46 could also be of like material to that of the dome shells 40 and 42 for higher load bearing capacity.
The dome shells 40 and 42 are sized relative to the spherical bearing portion 44 such that there are gap spacings 57 between peripheral end edges 58 and 60 of the respective shells 40 and 42 at their largest diameters and web wall 62 in the bearing 46, as best seen in the cross sectional views of
The web wall 62 extends laterally or radially and centrally from the ball bearing portion 44 to the annular load bearing portion 45 that extends about the ball bearing portion 44 on which the shells 40 and 42 ride. The circumferential web wall 62 extends radially for a sufficient distance, such that the outer bearing portion 45 is spaced from the ball bearing portion 44 to provide recesses 43 a and 43 b large enough to allow the dome edges 58 and 60 to slide into engagement with the web wall 62 without encountering interference from the annular load bearing portion 45 of the bearing 46.
In the device 38, the annular bearing portion 45 includes a radially inner surface 51 that extends generally axially or tangentially to outer spherical surface 44 a of the inner bearing portion 44, albeit spaced slightly therefrom via web wall 62. In this manner, the corresponding spaces 43 a and 43 b in the body 43 of the device 38 are enlarged over those in device 36 such that overhanging portions of the bearing portion 45 that can be compressed against the dome shell portions 47 and 49 and potentially cause binding in the spaces 43 a and 43 b are avoided.
With the above-described construction, the artificial disc devices 36 and 38 have a bi-polar construction in that relative movement between the vertebrae 20 and 22 and the dome shells 40 and 42 can occur along with relative movement between the dome shells 40 and 42 and the ball bearing portion 44. Generally, the smooth surface interface between inner surfaces 40 a and 42 a of the respective shells 40 and 42 and the outer surface 44 a of the ball bearing portion 44 will have a lower coefficient of friction therebetween than that between outer surfaces 40 b and 42 b of the respective shells 40 and 42 and the indents 27 and 29 in the vertebrae surfaces 20 a and 22 a. Thus, there will be some differential shifting that can occur with the moving components of the devices 36 and 38 such that generally the domes 40 and 42 will more readily shift along the ball bearing portion 44 prior to shifting of the dome shells 40 and 42 with respect to the vertebrae 20 and 22. Such differential articulation keeps wear between the higher coefficient of friction surfaces to a minimum as sliding can preferentially occur between the smooth inner arcuate surfaces 40 a and 42 a of the respective shells 40 and 42 and the outer surface 44 a of the ball bearing portion 44. Alternatively, if the coefficient of friction is lower between the vertebrae surface concave indents 27 and 29 and the shell outer surfaces 40 b and 42 b, then of course shifting will preferentially occur at this interface of the disc devices 36 and 38 keeping wear at the higher friction interface between the shell inner surfaces 40 a and 42 a and ball surface 44 a to a minimum. Of course, as the spine is undergoing various dynamic forces during the movements it is required to undertake, oftentimes both interfaces of the bi-polar devices 36 and 38 will be shifting simultaneously to provide the spine with the necessary biomechanics while also keeping undue wear on the disc devices 36 and 38 to a minimum.
The annular load bearing body portion 45 of the device 36 has an outer peripheral surface 66 (
Optionally, upper and lower annular layers including the flanges 70 and 72 can be provided of harder material than a more flexible core material of the bearing body 43 for optimized wear resistance at the interfaces with the vertebral surfaces 20 a and 22 a and also for improved shock absorbing properties for the device 38 a. For instance, the wear layers can be of hard polyethylene while the core of the body 43 would be of more flexible, e.g. elastomeric, cushioning material.
Referring next to
With the device 74 loaded and the confronting vertebral surfaces 20 a and 22 a engaging and pushing on the discs 82 and 84, they will shift and pivot relative to each other and axis 86 closing the gap 94 at certain locations thereabout and opening it at others. As such, it is the upper surface 82 a and lower surface 84 a of the respective upper and lower discs 82 and 84 that are the major load bearing surfaces for the device 74. As shown, these surfaces 82 a and 84 a can be contoured so that the respective discs become thicker as extending from the periphery toward the respective openings 88 and 90 of the discs 82 and 84.
In an alternative form, a resilient and flexible cushioning material 95 can be attached between the discs 82 and 84. The material 95 will keep the unloaded discs 82 and 84 in the illustrated, generally parallel orientation, but also allow them to undergo relative shifting under compressive loading. In this regard, the material 95 is selected so that it can resiliently expand and contract as the discs 82 and 84 shift and tilt or pivot with respect to each other. Alternatively, the unloaded discs 82 and 84 could be canted to a non-parallel orientation relative to each other to provide the disc device 74 with a wedged configuration similar to the previously-described device 10 a.
Accordingly and as described above, as the spine and particularly the vertebrae 20 and 22 exert compressive loading on the discs 82 and 84, they can shift relative to one another so they are better able to conform to the position of the vertebrae 20 and 22 as they shift with spine movement. For example, if the patient bends anteriorly, the upper disc 82 can tilt relative to the axis 86 so the gap spacing 94 between the discs 82 and 84 can be greater at the rear portion than at the forward portions thereof. In a like manner, if the patient bends their spine posteriorly, then the upper disc 82 can pivot about axis 86 such that the gap spacing 94 can be greater at the forward portions relative to the spacing at the rear portions. In each instance described above, there will usually be some tilting of the lower disc 84 as well although not to the same degree as that of the upper disc 82 so that their tilting movements relative to the axis 86 generally will correspond to that of the upper and lower vertebrae 20 and 22 and the surfaces 20 a and 22 a thereof relative to the axis of the spine.
The discs 82 and 84 can have a plan configuration akin to that of the lobed bearing 46, or alternatively they can be oval or ellipsoidal. As shown in the plan view of
The hub 110 can have a recess 112 which can engage against the distal curved end 114 of the post 108 to resist the compressive forces that otherwise would push the dome shells 104 and 106 further toward each other. More particularly, the dome shell 104 has an end edge 116 and the post 108 extends centrally from the shell 104 along axis 118 so that it projects beyond the edge 116. Likewise, the shell 106 includes an end edge 120 beyond which the hub 110 can project along the central axis 118 so that it is in alignment with the post 108. The post 108 and hub 110 have their respective sizes coordinated so that they define a limit at which spacing 122 between the dome shells 104 and 106 cannot be exceeded with the end edges 116 and 120 extending generally parallel to each other. In this manner, unlike the previously described central bearing assemblies 39 that rely on the stiffness or resilience of the polymeric spherical bearing portion 44 to resist compression of the dome shells 40 and 42, the dome shells 104 and 106 which are preferably of a harder material such as metal employ the cooperating integral post 108 and hub 110 for limiting the maximum compression that can occur therebetween. As is apparent, under normal conditions, the post 108 and hub 110 will be spaced or only lightly engaged so that they do not bear the loads generated between the vertebrae 20 and 22.
As mentioned above and referencing
Referring next to
The outer bearing body 148 has a central through opening 150 that is bounded by a cylindrical inner surface 152 in close confronting relation to outer side surface 154 on the post body 138. To provide optimized controlled resiliency of the shape retentive bearing body 148, through apertures 156 can be formed at selected locations extending axially therethrough, as shown in FIG. 10D. These apertures 156 provide an increase in the normal compressibility or coefficient of restitution of the material, e.g. plastic, of the bearing body 148. Based on the position, pattern and/or density of the through apertures 156, the flexibility or compressibility of the body 148 can be increased or decreased in a localized fashion. Of course, these apertures 156 could be employed in the other disc implants and specifically the bodies of the outer bearings thereof in a like fashion. Similarly, the previously-described liquid or gel material, e.g. Hydrogel, used in the outer bearing body 17 could also be provided in the apertures 156 so that they do not extend all the way through the body 138 and instead serve as chambers for the visco-elastic material therein to vary compressibility of the body 148.
For instance and as shown in the plan view of
As seen in the cross-sectional views of
An alternative disc device 175 is shown in
Accordingly, the surfaces 182 and 184 include radially extending bearing surface portions 182 a and 184 a that extend radially along the respective facing vertebral surfaces and central, axially extending bearings surface portions 182 b and 184 b that serve to locate the device 175 while also allowing relative sliding rotation of the vertebrae 20 and 22 thereabout and specifically 360° about device axis 186 since the plate members 176 and 178 are not fixed to the respective vertebrae 20 and 22. The center surface portion 182 b and 184 b only resist lateral sliding of the plates 176 and 178 by fitting in correspondingly shaped recesses or openings in the vertebral facing surfaces 20 and 22 a and otherwise are not fixed or fastened thereto.
As shown, the member 180 has a spherical ball configuration. The plates 176 and 178 have arcuate recessed surfaces 192 and 194 opposite their surfaces 182 and 184 and in which the ball member 180 seats. The ball member 180 can be of a harder material, e.g. steel, than the softer disc plate members 176 and 178. The materials for the members 176-180 is preferably selected for low frictional resistance to relative sliding movement therebetween to allow rotation of the members 176-180 such as when the spine is twisted and to allow relative sliding between the plate members 176 and 178 and ball 180 such as when the spine is bent in flexion and extension with the plates 176 and 178 pivoting with respect to each other. In this manner, the device 175 is bi-polar since there are two shifting interfaces thereof, i.e. between the plates 176 and 178 and the vertebrae 20 and 22 and between the ball 180 and the plates 176 and 178.
As is apparent, the various forms of artificial disc devices disclosed herein rely on both a center bearing portion and an outer, annular bearing portion extending about the center bearing portion to provide implants that resist migration without relying on disc fixing mechanisms such as intrusive bone fasteners, clamps and the like while also avoiding subsidence problems about the center bearing portion. To this end, the upper and lower arcuate surfaces of the center bearing or bearing portion or bearing assembly seat in correspondingly shaped recesses 27 and 29 in the vertebral surfaces 20 a and 22 a to locate the artificial disc device between the vertebrae 20 and 22. The interface between the center bearing surface portions and the recesses 27 and 29 is preferably a sliding one, i.e. not fixed, to substantially provide the vertebrae with their normal range of motion relative to each other with the discs implanted therebetween. And because of the enlarged axial spacing of the surface portions relative to the outer bearing portion, be they formed on separate components such as the dome shells or on a single part such as center ball or post bearings, the convex curvature of the center surface portions seated in the concave recesses provides resistance against migration or lateral shifting of the device out from between the vertebrae.
Extending about these axially projecting center bearing surface portions are outer bearing surface portions that also extend radially outwardly therefrom, generally with a more gradual curvature or with a flat configuration. As shown, the outer bearing surface portions extend so that their radial outer ends are close to the periphery of the respective vertebral bodies thereabove and therebelow. Accordingly, the upper outer bearing surface portion is generally lower than the axially projecting upper center bearing surface portion, and they form a juncture at which the direction in which the surface portions of the disc device for engaging the vertebrae changes or transitions from one extending more axially to one extending more radially. This juncture is a direction transition area and does not necessarily mean that the surface portions are joined thereat, such as can be seen with the previously-described ball bearing 12 and ring bearing 14 which are separate components with the ring bearing 14 extending annularly around the ball bearing 12 so as to allow for relative movement therebetween. Similarly, the lower outer bearing surface portion is generally higher than the axially projecting lower center bearing surface portion, and at their juncture the direction of the vertebral engagement surface portion of the device also changes as described above with respect to the upper vertebral engagement surface portions. In this manner, these radially extending outer surface portions limit the ability of the vertebrae or their attached end plates to subside around the center bearing. If there is any subsidence, its extent is limited by the axial spacing of the upper and lower outer bearing surface portions. In other words, in the area taken up by the artificial disc, the spacing of the upper and lower vertebrae can not be less than the spacing between the outer bearing surface portions, thereby limiting subsidence problems accordingly.
In another version of a disc device 200 in accordance with the above principles, upper and lower arcuate center bearing surface portions 202 and 204 that are convexly curved are provided for locating the device 200 between adjacent vertebrae in corresponding arcuate concave recesses formed therein. Upper and lower outer bearing surface portions 206 and 208 extend annularly about respective center bearing surface portions 202 and 204 and limit subsidence between the vertebrae about the center bearing portion 210 of the device 200. The upper surface portions 202 and 206 are formed integrally on an upper plate member 212, and the lower surface portions 204 and 208 are formed integrally on a lower plate member 214. The plate members 212 and 214 can be of a hard biocompatible material such as titanium coated with a pyroletic carbon. Like previously-described discs, the center bearing surface portions 202 and 204 are spaced by an axially greater distance than the outer bearing surface portions 206 and 208, and they have a smaller radius of curvature than the more gradual curvature of the surface portions 206 and 208. As such, as the vertebral engaging surface portions extend away from the disc axis 216, there is upper and lower junctures 218 and 220 where the direction and configuration of the surface portions undergo an abrupt change from one where the surface portion 202 or 204 extends more axially versus one where the surface portion 206 or 208 extends more radially to provide subsidence resistance about the center bearing 210. To this end, the plate members 212 and 214 include respective small, axial projections 213 and 215 that are centrally disposed relative to disc axis 216 and on which the respective center bearing surface portions 202 and 204 are formed.
As part of annular, outer bearing portion or assembly 222 extending about the center bearing assembly 210, an annular load bearing portion or member 224 is provided axially between the upper and lower bearing plates 212 and 214. The member 224 is preferably of a resilient material such as an elastomeric or resiliently compressible polymeric material, e.g. polyurethane and silicone combination, or a hydrogel material, for taking loads that are generated between the vertebrae during normal spinal movements. The annular member 224 has an axial thickness sized to maintain the plates 212 and 214 spaced axially by an anatomically correct distance from each other for engaging the vertebrae and keeping them properly spaced. At the same time, the resilient material of the load bearing member 224 allows the plates 212 and 214 to shift or deflect relative to each other during dynamic relative movements of the spine vertebrae 20 and 22 such as when the spine is being twisted and bent as in flexion or extension movements. For example, at one end of the disc 200, the plates 212 and 214 may be pivoting toward each other compressing the member 224 therebetween while at a generally diametrically opposite end the plates 212 and 214 will pivot or shift away from each other allowing for expansion of the resilient material of the member 224 in this area between the plates 212 and 214.
The annular bearing member 224 can be a composite to include a harder low friction wear coating on its upper and lower surfaces to allow the facing lower and upper surfaces of the respective upper and lower bearing plates 212 and 214 to minimize wear in this interface area such as when compressional and/or torsional forces are applied therebetween. Alternatively, upper and lower annular washers or wear plates 226 and 228 can be inserted in the interfaces between the upper bearing plate 212 and the load bearing member 224 and the lower bearing plate 214 and the load bearing member 224 to allow the plates 212 and 214 to have a low friction surface in engagement therewith.
The annular configuration of the load bearing member 224 of the outer bearing portion 222 forms an interior central space 230 in which a bumper or plug member 232 is provided as part of the center bearing portion 210 of the device 200. The bumper member 232 fits somewhat loosely in the interior space 230 and is of a harder material having a higher modulus of elasticity than the outer bearing member 224. Thus, the plug member 232 is operable during high impact loading on the vertebrae to keep the annular member 224 from deforming too much and overloading. In normal loading conditions, there is a spacing between the upper plate member 212 and the bumper member 232. The harder plug member 232 allows the annular member 224 to be softer so that its cushioning function between the vertebrae can be maximized. At the same time the material of the member 224 needs to be of sufficient stiffness or resiliency so as to be substantially shape retentive for maintaining stability between the vertebrae over millions of cycles and without experiencing undesirable material creep or plastic deformation due to the heavy loading it will undergo.
As can be seen in
It is also contemplated that the annular member 224 and plug member 232 could be integrally formed with one another, although having the members 224 and 232 as separate components is the preferred form for the present disc device 200.
As best seen in
Instead of the posts/recess or groove/ridge structure 250, the structure 250 can be provided at the periphery of the device 200, as shown in FIG. 12F. The upper plate 212 includes a downwardly extending peripheral lip projection 263, and the lower plate 214 includes an upwardly extending peripheral lip projection 264. The resilient member 224 is provided with peripheral grooves 266 and 268 in which the lips 262 and 264 extend so as to restrain the member 224 against lateral and rotational shifting relative to the plates 212 and 214.
While there have been illustrated and described particular embodiments of the present invention, it will be appreciated that numerous changes and modifications will occur to those skilled in the art, and it is intended in the appended claims to cover all those changes and modifications which fall within the true spirit and scope of the present invention.
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|U.S. Classification||623/17.16, 606/907, 606/247|
|International Classification||A61F2/30, A61F2/44, A61F2/00|
|Cooperative Classification||Y10S606/907, A61F2002/30331, A61F2230/0006, A61F2002/30649, A61F2002/30311, A61F2002/302, A61F2220/0025, A61F2002/30528, A61F2002/305, A61F2002/30563, A61F2230/0071, A61F2002/30581, A61F2002/443, A61F2/30742, A61F2250/0018, A61F2002/30299, A61F2220/0033, A61F2230/0093, A61F2002/30685, A61F2002/30934, A61F2/442, A61F2310/00017, A61F2310/00023, A61F2002/30784, A61F2002/30242, A61F2/30965, A61F2002/30123, A61F2230/0065, A61F2002/3039, A61F2002/30738, A61F2002/30673, A61F2002/30841, A61F2310/00179, A61F2002/30014, A61F2002/30919, A61F2002/30935, A61F2310/00574, A61F2250/0019, A61F2002/444, A61F2002/30016, A61F2002/30245, A61F2/4425|
|European Classification||A61F2/44D2, A61F2/44D|
|Mar 3, 2003||AS||Assignment|
Owner name: PIONEER LABORATORIES, INC., MICHIGAN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SONGER, MATTHEW N.;JANOWSKI, PRIAN P.;GEPHARD, MATTHEW;AND OTHERS;REEL/FRAME:013812/0196;SIGNING DATES FROM 20030214 TO 20030219
|Nov 14, 2007||AS||Assignment|
Owner name: PIONEER SURGICAL TECHNOLOGY, INC., MICHIGAN
Free format text: CHANGE OF NAME;ASSIGNOR:PIONEER LABORATORIES, INC.;REEL/FRAME:020105/0308
Effective date: 20061211
Owner name: PIONEER SURGICAL TECHNOLOGY, INC.,MICHIGAN
Free format text: CHANGE OF NAME;ASSIGNOR:PIONEER LABORATORIES, INC.;REEL/FRAME:020105/0308
Effective date: 20061211
|Aug 21, 2009||FPAY||Fee payment|
Year of fee payment: 4
|Feb 1, 2011||CC||Certificate of correction|
|Mar 1, 2011||CC||Certificate of correction|
|Mar 14, 2013||FPAY||Fee payment|
Year of fee payment: 8
|Jul 29, 2013||AS||Assignment|
Owner name: TD BANK, N.A., AS ADMINISTRATIVE AGENT, FLORIDA
Free format text: SECURITY AGREEMENT;ASSIGNOR:PIONEER SURGICAL TECHNOLOGY, INC.;REEL/FRAME:030892/0193
Effective date: 20130716
|Oct 8, 2013||SULP||Surcharge for late payment|